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US Agencies OK Resumption of J&J COVID Vaccine Use Despite Clot Risk

FILE - Boxes of the Johnson & Johnson COVID-19 vaccine are seen at the McKesson Corp., amid the coronavirus disease outbreak, in Shepherdsville, Ky., March 1, 2021.

U.S. health officials on Friday ended an 11-day pause on COVID-19 vaccinations using Johnson & Johnson's one-dose shot, after scientific advisers decided its benefits outweighed the risk of rare blood clots.

The government found 15 vaccine recipients who had developed the clots, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died; seven are still in hospitals.

In the end, however, the Food and Drug Administration and Centers for Disease Control and Prevention decided that J&J's vaccine was a key to fighting the pandemic, and that the clot risk could be addressed with warnings to help younger women decide which shot to choose.

The Advisory Committee on Immunization Practices' meeting on Friday followed an emergency meeting last week, the day after the announcement of the pause. At that time, members of the panel said they had too little time to make a recommendation.

On Friday, members voted 10-4 for the resumption of the use of the vaccine. The panel debated imposing age restrictions on the vaccine but decided against it.

On April 13, the CDC, in a joint statement with the FDA, recommended pausing use of the vaccine “out of an abundance of caution” to give experts an opportunity to examine six cases of blood clots and to see if any additional cases were found.

CDC officials later said that “a handful” of other cases were being investigated and that they were encouraged by the relatively small number of them.

Earlier this week, Europe’s drug watchdog group, the European Medicines Agency, said that while it found a possible link between the Johnson & Johnson vaccine and the rare blood clots, the vaccine’s benefits outweighed its risks.

It said it would recommend its use with an additional warning included in the information about the vaccine.

European regulators already had uncovered similar rare blood clots among recipients of another COVID-19 vaccine, from AstraZeneca. The AstraZeneca and Johnson & Johnson vaccines, while not identical, are made with similar technology.